PMA P150012S039
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S039
- Product code
- LWP
- Decision date
- 2017-09-11
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the Model 3300 LATITUDE Programming System.
Current openFDA PMA Record#
- Device
- INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S039
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-09-11
- Decision code
- APPR
- Date received
- 2017-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Model 3300 LATITUDE Programming System.